Z-1731-2024Class II

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Name: Z-1731-2024 Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Creator: Covidien
Published: 2024-01-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-01-09 / Open, Classified / root cause: manufacturing process

FDA source

Covidien began a recall of Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC on 2024-01-09. FDA classified it as Class II and gives the reason as "manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1731-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2024-04-30
Recalling firm: Medtronic, Inc.
Product: Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Product code: MUD Oximeter, Tissue Saturation
Reason for recall: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On January 9, 2024 Medtronic (parent company of Covidien) issued a Urgent Medical Device Recall notification via UPS. Medtronic asked consignees to take the following action: 1. Quarantine and stop using all product from the affected lots of INVOS" Reusable Sensor Cables PMAC71RSC and PMAC71RIC. " See attachment A for guidance on how to identify affected devices via cable box packaging or cable hang tag. 2. Complete and return Customer Confirmation Form. Complete and return the enclosed Customer Confirmation Form even if you do not have any affected lots remaining. 3. Reach out to Medtronic to obtain RGA # /Returned Goods Authorization number. " Your Medtronic Representative / Medtronic Customer Service at [email protected] can assist in initiating product return as necessary. 4. Return all product from the affected lots in your possession to Medtronic as described on the Customer Confirmation Form. 5. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.
Quantity in commerce: 1122 units
Distribution: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
Product codes and lots: Lot # 20221220 and 20230721; UDI: 10884521806436

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1731-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1731-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30
Z-1732-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-04-30

Product code MUD

K211561Class IIINVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)Covidien, LLC / cleared 2021-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)